Achieving Safety, Efficiency, and Flexibility in ADC Manufacturing

Achieving Safety, Efficiency, and Flexibility in ADC Manufacturing

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Overview

Antibody-drug conjugates (ADCs) combine the specificity of monoclonal antibodies with the potency of highly cytotoxic payloads to deliver targeted cancer therapies. Manufacturing ADCs remains demanding: extremely potent payloads require stringent containment, organic solvents can promote aggregation, and achieving an optimal drug-to-antibody ratio (DAR) places pressure on manufacturers.

The white paper reviews these hurdles and explains how closed, single-use systems can support reliable and scalable ADC production. It also provides results for an extractables study of single-use tubing and filter components used in settings relevant to ADC manufacturing.

Key Objectives:

The importance of ADCs in cancer therapy and the distinct manufacturing challenges they present.
How the use of closed, single-use systems in ADC manufacturing enhances safety, efficiency, and flexibility.
Demonstrate through a case study how single-use assemblies show negligible extractables in simulated real-world conditions.

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